access to controlled drugs for medical purposes while ... · gilberto gerra drug prevention and...

Gilberto Gerra

Drug Prevention and Health Branch

Access to controlled drugs

for medical purposes

while preventing misuse and diversion

The Single Convention recognizes the medical use of narcotic

drugs as indispensable for the relief of pain and suffering

and that adequate provision must be made to ensure the availability

of narcotic drugs for this purpose.

1961 Single Convention, as amended by the 1972 Protocol

INCB WHOUNODC

Commission on Narcotic Drugs

National drug control system

Resolution 53/4 and Resolution 54/6

of the

Commission on Narcotic Drugs

Promote adequate availability of internationally controlled drugs

for medical and scientific purposes,

while preventing their diversion and abuse

Access to controlled medications

not existent

or almost not existent

in many countries

2010

CONTROLLED DRUGS USED FOR MEDICAL PURPOSES

Access to controlled drugs for medical purposes

Recognize the dramatic situation of lack of access to pain medication

for 80% of the world population

Correct unduly restrictive regulations

Implementing regulatory , financial, educational, administrative measures

Legislation revision

Training competent national authorities, health professionals, including pharmacists

Expedite the process of issuing import export authorizations

for controlled substances for medical purposes (guidance INCB)

UN General Assembly, 2016

Help Member States to improve availability

of and accessibility to controlled drugs for

medical purposes

Help Member States to control

diversion misuse and abuse

Protecting the health of people

from the dangerous effects of drugs

is not in conflict with

promoting

the medical and scientific use

of controlled drugs

Balance between control and availability

Medical purpose:

indispensable

Non-medical purpose:

not permitted

Ketamine:

used for humans

in low income countries

A dissociative anaesthetic

NMDA antagonist

(glutamate antagonist)

Pain relief recognized as part of the human right to the

highest attainable standards of mental and physical health

Opioid medications essential for treatment

of severe pain (acute pain, cancer pain)

Disparity in the global consumption or access

to pain medication

• High income countries:

• 812 - 749 ME/mg/cap

• Low income countries:

• 0.014 - 0.015 ME/mg/cap

• High income countries 17 % of population

account 92% of medical morphine

Koike et al., 2014

Reduced lymphocytes:

lower CD8(+)

Immune function significantly

and specifically suppressed in pain

Chronic

severe pain

extracellular

signal-regulated

kinases 1 and 2 (ERK1/2)

(spinal cord level)

Borges et al. 2015

Pain

emotional-affective component

depression and anxiety

Relationship between Nonmedical Prescription-Opioid Use and Heroin Use

Wilson M. Compton et al., 2016, N Engl J Med

The need of interpretation in depth:

Sociological and psychological studies

Qualitative studies

Who dies? Characteristics of the people affected

Subgroups: from pain treatment, from drug use disorders, from recreational use?

Who is more vulnerable?

AVAILABILITY PER SE CANNOT EXPLAIN THE EPIDEMIC

A large rate of overdoses is not “unintentional”:

They are suicide cases.

World Drug Report

2018

0.00

1.00

2.00

3.00

4.00

5.00

6.00

1.00

5.20

3.10

1.00 1.04

0.60

0.10

2.60

0.100.27 0.40

0.55

1.50

3.60

Annual prevalence of misuse of prescription opioids (%)

0

100

200

300

400

500

600

700

800

900 812.

749.8

362.7

159.7

82.9 68.8 30.50.39 0.018 0.014

Per capita consumption of opioid painkillers (ME mg/cap)

• Government import-export authorization

• Provision to the INCB annually of estimates of medical and scientific needs

for narcotic drugs

• Record-keeping by governmental authorities and persons engaged

in manufacture, trade and distribution, and conduct of inspections by government

• Requirement of medical prescriptions for supply or dispensation to individuals

• Prohibition of advertising to the general public with due regard to constitutional

provisions

• Requirement of adequate labelling

• Requirements for commercial documents

• Prohibition of export to post office box

• Establishment of penal provisions for contraventions of the above requirements

Provisions of the Conventions

• Limitations on the number of days supply that may be provided in a single

prescription;

• Limitations on doses that may be prescribed in a single prescription;

• Excessive limitations on prescription authority, such as only to some categories

of medical doctors;

• Special prescription procedures for opioids, for example, the use of specific prescription

forms, which may be difficult to obtain, and/or a requirement that multiple copies of

the prescription be maintained;

• Requirements that patients receive special permission or registration to render them

eligible to receive opioid prescriptions;

• Excessive penalties and prosecutions for unintentional mis-prescription or mishandling

of opioids;

• Arbitrary restrictions on the number of pharmacies permitted to dispense opioid

medications;

• Unreasonable requirements relating to the storage of opioid medications.

Additional restrictive measures:

Department of

Essential Medicines

and Health Products

Drug Prevention

and Health Branch

WHO

Union for

International Cancer Control

GLO-K67

To reduce the barriers

Professionals qualification (training)

Financial (cost of medications/distribution)

Legal (national legislation overruling)

Logistic (distribution/storage modality)

Cultural (mentality attitude)

Prepare a new generation of:

Health professionals

Policy makers

Law makers

Family to family programs:

Public opinion mentality

Response to Pain

Dismantling prejudices

Pain medications per se create “addiction”

Pain medications undermine identity

Using analgesics is materialistic /

as opposed to pain acceptance, that is spiritual

Using analgesics is a sign of fragility

and lack of willpower

Concurring to dependence:

Drug

Brain

adaptation

Drug

Brain

adaptation

Gene/

Environmental

factors

Concurring to addiction:

Compulsive behaviour

To avoid diversion and abuse

appropriate rules in line with the Conventions

systematic monitoring

case by case management and screening

interpersonal relationship patient/doctor:

therapeutic alliance

Addiction.

Non-medical use of prescription opioids and prescription opioid-related harms:

why so markedly higher in North America compared to the rest of the world?

Fischer et al., 2014

Dispensing levels related to harms

Lesser regulatory access restrictions for

community-based dispensing mechanisms

Facilitating higher dissemination level and availability

(e.g. through diversion)

Medical-professional culture and attitude

Patient expectations for “immediately effective treatment”

More pronounced 'for-profit' orientation of key

elements of health care (including pharmaceutical advertising),

1% of doctors responsible

for

25% of opioid prescriptions

Persons who are prescribed opioids

also are commonly prescribed

benzodiazepines

Opioid prescribing rates peaked in either

the 45-54 years or the 55-64 years age

group.

MMWR Surveill Summ.

Controlled Substance Prescribing Patterns - Prescription Behavior

Surveillance System, Eight States, 2013.

Paulozzi et al., 2015

1%

99%

MD MDOP OP

Continuing evolution of opioid use in primary care practice:

implications of emerging technologies.Stanos, 2012

Opioid treatment decisions are based

not only on the type of pain

but also the patient's psychosocial history

A screening for predicting

- aberrant drug-related behaviours;

- risk factor stratification;

- utilization of opioid screening tools

- urine drug testing

Sehgal et al., 2012

1. Focus on opioids/preference/ allergy for other medications

2. Opioid overuse / stolen prescription

3. Other substance abuse/ alcohol abuse

4. Low functional status

5. Unclear aetiology of pain

6. Exaggeration of pain / Old X-ray documentation

- Women

- Young 18-25/26-34

- Childhood - adolescence adverse experiences

- History of mental health

- History of substance abuse

- Multiple prescribers and pharmacies

- History of overdose

Screening

List of Opioid Risk Screening Tools

Screener and Opioid Assessment for Patients in Pain-Revised

(SOAPP-R).

Current Opioid Misuse Measure (COMM).

Opioid Risk Tool (ORT).

Diagnosis, Intractability, Risk, and Efficacy (DIRE).

Screening Instrument for Substance Abuse Potential (SISAP).

The Pain Assessment and Documentation Tool (PADT).

The aim of screening is not to exclude people in need

from appropriate pain treatment

Not to deny medication provision when it is necessary

More accurate

monitoring

Daily medical

supervision

providing drugs together with

interpersonal relationships,

compassion and support

Cancer has long been neglected in developing countries, overshadowed

WHO expects the burden of cancer

in sub-Saharan Africa to grow rapidly:

incidence to exceed 1 million per year by 2030

Little access to diagnostic technology.

80% of cases are in terminal stages

at the time of diagnosis

Large proportion of patients with severe pain

O'Brien et al., 2013

complex questions about pain,

suffering and mankind condition

full respect for individuals attitude,

culture, religion and personal view

The suffering of any human being is my suffering…

some of the same regions of the brain

are activated by personal pain, at left,

and by empathy over the pain

of a loved one, at right.

Empathy neurobiological background

e-mail

gilberto.gerra@un.org

twitter

@gilbertogerra